Praxis shares surge 47.31% after hours on positive FDA pre-NDA alignment and early EMBOLD trial efficacy results for relutrigine.

Praxis Precision Medicines surged 47.31% in after-hours trading following two major positive developments. First, the company announced successful completion of a pre-NDA meeting with the FDA for ulixacaltamide, aligning on the New Drug Application (NDA) content for treating essential tremor, with submission expected in early 2026. Second, its EMBOLD trial evaluating relutrigine for SCN2A/SCN8A developmental and epileptic encephalopathies (DEEs) was halted early by a Data Monitoring Committee due to positive efficacy results, with topline data to be presented at the American Epilepsy Society Annual Meeting. Both events signal regulatory and clinical progress, addressing significant unmet medical needs in movement disorders and rare epilepsies. The FDA meeting and trial success reinforced investor confidence in Praxis’ pipeline, driving the sharp after-hours gain.